11 results · 31ms · Sources: EU EUDAMED, US FDA

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Aplicare Lubricating Jelly

FDA UDI
APLICARE, INC.·00618407002802·Lubricating Jelly

Aplicare Lubricating Jelly

FDA UDI
APLICARE, INC.·00618407002819·Lubricating Jelly

ENDOVIVE

FDA Adverse Event
Malfunction ·BOSTON SCIENTIFIC·Product code KNT·September 12, 2011

APLICARE

FDA Adverse Event
Other ·APLICARE, INC·Product code GEC·January 23, 2004

APLICARE

FDA Adverse Event
Other ·APLICARE, INC.·Product code GEC·January 23, 2004

PREVAIL FX - 72%

FDA Adverse Event
Injury ·APLICARE, INC.·Product code KXG·March 4, 2003

Aplicare Advantage Dressing Change System, Central Line Dressing Change, Sterile Part number: A3402. The product is used for Central Line Dressing Change.

FDA Recall
Terminated ·Aplicare, Inc.·Product code NAD·March 3, 2010

Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Enforcement
Class II ·Terminated·Smiths Medical ASD Inc.·February 27, 2019

Aplicare Povidone Iodine Prep Pads packaged within Portex Pulsator Arterial Blood Sampling Kit with Liquid Sodium Heparin, models 4037NP-1, 4039-1, 4039EG-1, 4044EG-1, 4044P-1, 4057NP-1, 4067NP-1, 4077EG-1, 4077NP-1, 4084P-1, G1193, G1374, G1585, G1589, G1598, G1621, and G1806. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code JKA·June 22, 2018

Aplicare Povidone Iodine Prep Pads packaged within Portex Pro-Vent Arterial Blood Sampling Kit with Dry Lithium Heparin for Gases and Electrolytes, models 4589P-1, 4591EG-1, 4591P-1, 4599P-1, 4611LH, 4611P-1, 4620EG-1, 4620P-1, 4640LH, 4640P-1, 4649P-1, 4660EG-1, 4660P-1, 4699LH, 4699P-1, G1325, G1412, G1481, G1509, G1548, G1581, G1586, G1602, G1627, G1632, G1634, G1671, G1675, G1716, G1724, G1773, and G1807. The firm name on the label is Smiths Medical ASD, Inc., Keene, NH.

FDA Recall
Terminated ·Smiths Medical ASD Inc.·Product code JKA·June 22, 2018